A 6-Hour Clinical Evaluation of New Daily-Wear Soft Contact Lenses

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03235089
• Collaborator: (none)
• Enrollment: 31
• Location: 1
• Arms: 2
• Actual Duration (Days): 9
• Patients Per Site Per Month: 104.8

Study Details

Study Description

Brief Summary

The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period of 6 hours compared to nelfilcon A (control).

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Test Lens; Device: Control Lens	N/A

Detailed Description

The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period of 6 hours compared to nelfilcon A (control). The primary outcomes of interest are lens fit and lens fit preference.

Study Design

• Study Type: Interventional
• Actual Enrollment: 31 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: This will be a non-dispensing, double-masked, contralateral study comparing test contact lens against a nelfilcon A control lens. Subjects will be randomized to wear the test lens in one eye and the control lens in the other. It is anticipated that this study will involve up to 2 scheduled visits, at Baseline (BL) and 6 hours.This will be a non-dispensing, double-masked, contralateral study comparing test contact lens against a nelfilcon A control lens. Subjects will be randomized to wear the test lens in one eye and the control lens in the other. It is anticipated that this study will involve up to 2 scheduled visits, at Baseline (BL) and 6 hours.
• Masking: Double (Participant, Investigator)
• Masking Description: Both subject and investigator will be masked to lens type for each eye. A different investigator will select the study lenses for insertion by the subject, from those performing the assessments in order to maintain masking.
• Primary Purpose: Treatment
• Official Title: A 6-Hour Clinical Evaluation of New Daily-Wear Soft Contact Lenses
• Actual Study Start Date: Jul 25, 2017
• Actual Primary Completion Date: Aug 3, 2017
• Actual Study Completion Date: Aug 3, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Test lens Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule (to determine which eye receives test/control lens).	Device: Test Lens; Daily disposable contact lens; Device: Control Lens; Focus Dailies All Day Comfort contact lens (nelfilcon A)
Active Comparator: nelfilcon A lens (control) Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule (to determine which eye receives test/control lens).	Device: Test Lens; Daily disposable contact lens; Device: Control Lens; Focus Dailies All Day Comfort contact lens (nelfilcon A)

Outcome Measures

Primary Outcome Measures

1. Horizontal Lens Centration Assessed in Primary Gaze [Baseline]

   Horizontal Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-nasal decentration given +ve value, temporal decentration given -ve value)

2. Horizontal Lens Centration Assessed in Primary Gaze [6-hour]

   Horizontal Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-nasal decentration given +ve value, temporal decentration given -ve value)

3. Vertical Lens Centration Assessed in Primary Gaze [Baseline]

   Vertical Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-superior decentration given +ve value, inferior decentration given -ve value)

4. Vertical Lens Centration Assessed in Primary Gaze [6-hours]

   Vertical Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-superior decentration given +ve value, inferior decentration given -ve value)

5. Lens Tightness Assessed by Push-up Test [Baseline]

   Lens Tightness was assessed by Push-up test 1% steps: (0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement)

6. Lens Tightness Assessed by Push-up Test [6-hours]

   Lens Tightness was assessed by Push-up test 1% steps: (0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement)

7. Primary Gaze Lag Assessed Observing Lens Movement in Graticule [Baseline]

   Primary gaze lag was assessed observing lens movement in graticule (0.1mm steps)

8. Primary Gaze Lag Assessed Observing Lens Movement in Graticule [6 hours]

   Primary gaze lag was assessed observing lens movement in graticule (0.1mm steps)

9. Horizontal Lens Lag Assessed Observing Lens Movement in Graticule [Baseline]

   Horizontal lens lag was assessed observing lens movement in graticule (0.1mm steps)

10. Horizontal Lens Lag Assessed Observing Lens Movement in Graticule [6 hours]

    Horizontal lens lag was assessed observing lens movement in graticule (0.1mm steps)

11. Overall Lens Fit Acceptance [Baseline]

    Overall lens fit acceptance based on lens fit alone (scale 0-4 in 0.25 steps: 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)

12. Overall Lens Fit Acceptance [6 hours]

    Overall lens fit acceptance based on lens fit alone (scale 0-4 in 0.25 steps: 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)

13. Up Gaze Lag Assessed Observing Lens Movement in Graticule [Baseline]

    Up gaze lag was assessed observing lens movement in graticule (0.1mm steps) (The amount of lens drop in mm that occurs when the eye moves from primary gaze to up gaze).

14. Up Gaze Lag Assessed Observing Lens Movement in Graticule [6 hours]

    Up gaze lag was assessed observing lens movement in graticule (0.1mm steps) (The amount of lens drop in mm that occurs when the eye moves from primary gaze to up gaze).

15. Post-blink Movement Assessed by Amount of Lens Movement Immediately After the Blink [Baseline]

    Post-blink Movement was assessed by amount of movement (to the nearest 0.1mm) immediately after the blink

16. Post-blink Movement Assessed by Amount of Lens Movement Immediately After the Blink [6 hours]

    Post-blink Movement was assessed by amount of movement (to the nearest 0.1mm) immediately after the blink

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Is at least 18 years of age and has full legal capacity to volunteer

• Has read, fully understood and signed the information consent letter

• Currently wears or has previously worn soft contact lenses

• Has spectacle cylinder ≤1.00D in both eyes.

• Has spherical contact lens power requirement between -1.00D and -6.00D in both eyes.

• Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye.

• Has clear corneas and no active ocular disease

• Is willing and able to follow product usage instructions and maintain the visit schedule.

Exclusion Criteria:

• Has never worn contact lenses before

• Has a systemic condition that in the opinion of the investigator may affect a study outcome variable

• Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable

• Has any known active ocular disease and/or infection

• Has a monovision correction

• Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses

• Is aphakic

• Has undergone corneal refractive surgery

• Is pregnant or lactating, determined by self-report

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University	Bloomington	Indiana	United States	47405

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 18, 2017

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT03235089
• Other Study ID Numbers: CV-17-46
• First Posted: Aug 1, 2017
• Last Update Posted: Oct 14, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Arm/Group Title	Test Lens	Nelfilcon A Lens (Control)
Arm/Group Description	Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Test Lens: Daily disposable contact lens	Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)
Period Title: Overall Study
STARTED	31	31
COMPLETED	28	28
NOT COMPLETED	3	3

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description	Subjects were randomized to wear test lens in one eye and control lens in other eye for 6 hours.
Overall Participants	28
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	28 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29 (9)
Sex: Female, Male (Count of Participants)
Female	19 67.9%
Male	9 32.1%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	28 100%

Outcome Measures

1. Primary Outcome

Title	Horizontal Lens Centration Assessed in Primary Gaze
Description	Horizontal Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-nasal decentration given +ve value, temporal decentration given -ve value)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Nelfilcon A Lens (Control)
Arm/Group Description	Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Test Lens: Daily disposable contact lens	Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)
Measure Participants	28	28
Measure Eyes	28	28
Mean (Standard Deviation) [millimeters]	-0.13 (0.20)	-0.04 (0.21)

2. Primary Outcome

Title	Horizontal Lens Centration Assessed in Primary Gaze
Description	Horizontal Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-nasal decentration given +ve value, temporal decentration given -ve value)
Time Frame	6-hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Nelfilcon A Lens (Control)
Arm/Group Description	Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Test Lens: Daily disposable contact lens	Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)
Measure Participants	28	28
Measure Eyes	28	28
Mean (Standard Deviation) [millimeters]	-0.15 (0.20)	-0.06 (0.16)

3. Primary Outcome

Title	Vertical Lens Centration Assessed in Primary Gaze
Description	Vertical Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-superior decentration given +ve value, inferior decentration given -ve value)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Nelfilcon A Lens (Control)
Arm/Group Description	Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Test Lens: Daily disposable contact lens	Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)
Measure Participants	28	28
Measure Eyes	28	28
Mean (Standard Deviation) [millimeters]	0.17 (0.25)	0.06 (0.20)

4. Primary Outcome

Title	Vertical Lens Centration Assessed in Primary Gaze
Description	Vertical Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-superior decentration given +ve value, inferior decentration given -ve value)
Time Frame	6-hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Nelfilcon A Lens (Control)
Arm/Group Description	Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Test Lens: Daily disposable contact lens	Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)
Measure Participants	28	28
Measure Eyes	28	28
Mean (Standard Deviation) [millimeters]	0.10 (0.22)	-0.03 (0.25)

5. Primary Outcome

Title	Lens Tightness Assessed by Push-up Test
Description	Lens Tightness was assessed by Push-up test 1% steps: (0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Nelfilcon A Lens (Control)
Arm/Group Description	Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Test Lens: Daily disposable contact lens	Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)
Measure Participants	28	28
Measure Eyes	28	28
Mean (Standard Deviation) [units on a scale]	38 (7)	41 (6)

6. Primary Outcome

Title	Lens Tightness Assessed by Push-up Test
Description	Lens Tightness was assessed by Push-up test 1% steps: (0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement)
Time Frame	6-hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Nelfilcon A Lens (Control)
Arm/Group Description	Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Test Lens: Daily disposable contact lens	Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)
Measure Participants	28	28
Measure Eyes	28	28
Mean (Standard Deviation) [units on a scale]	41 (8)	49 (6)

7. Primary Outcome

Title	Primary Gaze Lag Assessed Observing Lens Movement in Graticule
Description	Primary gaze lag was assessed observing lens movement in graticule (0.1mm steps)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Nelfilcon A Lens (Control)
Arm/Group Description	Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Test Lens: Daily disposable contact lens	Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)
Measure Participants	28	28
Measure Eyes	28	28
Mean (Standard Deviation) [millimeters]	0.16 (0.06)	0.13 (0.05)

8. Primary Outcome

Title	Primary Gaze Lag Assessed Observing Lens Movement in Graticule
Description	Primary gaze lag was assessed observing lens movement in graticule (0.1mm steps)
Time Frame	6 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Nelfilcon A Lens (Control)
Arm/Group Description	Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Test Lens: Daily disposable contact lens	Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)
Measure Participants	28	28
Measure Eyes	28	28
Mean (Standard Deviation) [millimeters]	0.18 (0.08)	0.12 (0.04)

9. Primary Outcome

Title	Horizontal Lens Lag Assessed Observing Lens Movement in Graticule
Description	Horizontal lens lag was assessed observing lens movement in graticule (0.1mm steps)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Nelfilcon A Lens (Control)
Arm/Group Description	Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Test Lens: Daily disposable contact lens	Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)
Measure Participants	28	28
Measure Eyes	28	28
Mean (Standard Deviation) [millimeters]	3.1 (0.3)	2.7 (0.3)

10. Primary Outcome

Title	Horizontal Lens Lag Assessed Observing Lens Movement in Graticule
Description	Horizontal lens lag was assessed observing lens movement in graticule (0.1mm steps)
Time Frame	6 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Nelfilcon A Lens (Control)
Arm/Group Description	Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Test Lens: Daily disposable contact lens	Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)
Measure Participants	28	28
Measure Eyes	28	28
Mean (Standard Deviation) [millimeters]	3.0 (0.3)	2.7 (0.4)

11. Primary Outcome

Title	Overall Lens Fit Acceptance
Description	Overall lens fit acceptance based on lens fit alone (scale 0-4 in 0.25 steps: 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Nelfilcon A Lens ( Control)
Arm/Group Description	Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Test Lens: Daily disposable contact lens	Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)
Measure Participants	28	28
Measure Eyes	28	28
Mean (Standard Deviation) [units on a scale]	2.7 (0.6)	3.1 (0.4)

12. Primary Outcome

Title	Overall Lens Fit Acceptance
Description	Overall lens fit acceptance based on lens fit alone (scale 0-4 in 0.25 steps: 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)
Time Frame	6 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Nelfilcon A Lens (Control)
Arm/Group Description	Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Test Lens: Daily disposable contact lens	Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)
Measure Participants	28	28
Measure Eyes	28	28
Mean (Standard Deviation) [units on a scale]	2.7 (0.5)	3.0 (0.5)

13. Primary Outcome

Title	Up Gaze Lag Assessed Observing Lens Movement in Graticule
Description	Up gaze lag was assessed observing lens movement in graticule (0.1mm steps) (The amount of lens drop in mm that occurs when the eye moves from primary gaze to up gaze).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Nelfilcon A Lens (Control)
Arm/Group Description	Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Test Lens: Daily disposable contact lens	Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)
Measure Participants	28	28
Measure Eyes	28	28
Mean (Standard Deviation) [millimeters]	0.41 (0.18)	0.38 (0.16)

14. Primary Outcome

Title	Up Gaze Lag Assessed Observing Lens Movement in Graticule
Description	Up gaze lag was assessed observing lens movement in graticule (0.1mm steps) (The amount of lens drop in mm that occurs when the eye moves from primary gaze to up gaze).
Time Frame	6 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Nelfilcon A Lens (Control)
Arm/Group Description	Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Test Lens: Daily disposable contact lens	Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)
Measure Participants	28	28
Measure Eyes	28	28
Mean (Standard Deviation) [millimeters]	0.34 (0.11)	0.35 (0.14)

15. Primary Outcome

Title	Post-blink Movement Assessed by Amount of Lens Movement Immediately After the Blink
Description	Post-blink Movement was assessed by amount of movement (to the nearest 0.1mm) immediately after the blink
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Nelfilcon A Lens (Control)
Arm/Group Description	Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Test Lens: Daily disposable contact lens	Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)
Measure Participants	28	28
Measure Eyes	28	28
Mean (Standard Deviation) [millimeters]	0.44 (0.14)	0.31 (0.11)

16. Primary Outcome

Title	Post-blink Movement Assessed by Amount of Lens Movement Immediately After the Blink
Description	Post-blink Movement was assessed by amount of movement (to the nearest 0.1mm) immediately after the blink
Time Frame	6 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Nelfilcon A Lens (Control)
Arm/Group Description	Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Test Lens: Daily disposable contact lens	Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)
Measure Participants	28	28
Measure Eyes	28	28
Mean (Standard Deviation) [millimeters]	0.43 (0.17)	0.29 (0.11)

Adverse Events

Time Frame	From dispense up to 6 hours on each type of study lenses
Arm/Group Title	Test Lens		Nelfilcon A Lens ( Control)
Arm/Group Description	Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Test Lens: Daily disposable contact lens		Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)
All Cause Mortality
	Test Lens		Nelfilcon A Lens ( Control)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/28 (0%)
Serious Adverse Events
	Test Lens		Nelfilcon A Lens ( Control)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/28 (0%)
Other (Not Including Serious) Adverse Events
	Test Lens		Nelfilcon A Lens ( Control)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/28 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.